Device Recall Pinnacle Destination Guiding Sheath, 7 French, 90 cm

  • Model / Serial
    RSC02
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AK, AZ, TX, LA, MS, MN, MO, CA, GA, FL, HI, KS, IA, ID, IL, TN, NM, OR, OK, WA, and WI and the countries of Belgium, Brazil, and Panama
  • Product Description
    Pinnacle Destination Guiding Sheath, 7 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lots ME07 & MF12, 510(k) K052185 || Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Terumo Medical Corporation, 950 Elkton Blvd, Elkton MD 21921-5322
  • Manufacturer Parent Company (2017)
  • Source
    USFDA